Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

European Commission Oks Novartis' Afinitor Tablets For Treatment Of HR+/HER2

Novartis International AG (NVS: Quote) said the European Commission has approved Afinitor (everolimus) tablets for treatment of hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced breast cancer (HR+ advanced breast cancer), in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.

The approval was based on the Phase III BOLERO-2 trial. The randomized, double-blind, placebo-controlled, multi-center study of 724 patients found that treatment with Afinitor plus exemestane more than doubled median progression-free survival, or PFS, to 7.8 months, compared to 3.2 months with exemestane alone, by local investigator assessment.

Besides, an additional analysis based on an independent central radiology review showed Afinitor extended median PFS to 11.0 months compared to 4.1 months. The most common grade 3-4 adverse reactions were stomatitis, infections, hyperglycemia, fatigue, dyspnea, pneumonitis and diarrhea.

Click here to receive FREE breaking news email alerts for Novartis AG and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
After reporting four consecutive monthly increases, the National Association of Realtors released a report on Monday showing an unexpected drop in U.S. existing home sales in the month of August. NAR said existing home sales fell 1.8 percent to a seasonally adjusted annual rate of 5.05 million in August. The European Central Bank remains ready to use additional unconventional tools to counter risks to the inflation outlook and to boost the euro area economy, ECB President Mario Draghi said on Monday. "The Governing Council remains fully determined to counter risks to the medium-term outlook for inflation," Draghi said in Brussels. Stocks have moved to the downside in early trading on Monday, giving back some ground after moving mostly higher last week. The major averages have all dipped into negative territory, although selling pressure has remained somewhat subdued.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.